NCT00248118

Brief Summary

The purpose of this study is to determine: 1) the short-term clinical efficacy and safety of bupropion for helping adolescent tobacco smokers quit, and 2) The role of withdrawal symptoms in the maintenance of smoking in adolescents.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

2.6 years

First QC Date

November 1, 2005

Last Update Submit

September 22, 2016

Conditions

Tobacco Dependence

Keywords

RandomizedDouble-blindPlacebo-controlled

Outcome Measures

Primary Outcomes (1)

  • Bupropion will be safe and tolerable, increase cessation rates, and reduce smoke and nicotine exposure

    7 weeks

Secondary Outcomes (1)

  • Reduction of smoking-related urges and cravings.

    7 weeks

Study Arms (2)

Active medication

ACTIVE COMPARATOR

300mg bupropion HCL

Drug: Bupropion

Placebo

PLACEBO COMPARATOR

Placebo pill

Drug: Bupropion

Interventions

BupropionDRUG

During treatment phase, participants will take 300 mg bupropion or placebo daily.

Also known as: Wellbutrin, Zyban
Active medicationPlacebo

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • More than 100 lbs
  • IQ greater than 80
  • General good health
  • Not pregnant
  • Non-Smoker: No cigarettes in last 6 months, less than 5 in lifetime
  • Smokers: Smoke more than 6 cigarettes per day for at least 6 months

You may not qualify if:

  • Cardiac, Central Nervous System (CNS) or severe psychiatric disorder
  • Psychoactive medications (including nicotine replacement)
  • Substance use disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Teen Tobacco Addiction Research Clinic, NIDA Intramural Research Program

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Study Officials

  • Eric T. Moolchan, M.D.

    National Institute on Drug Abuse, Intramural Research Program

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2005

First Posted

November 3, 2005

Study Start

January 1, 2005

Primary Completion

August 1, 2007

Study Completion

May 1, 2008

Last Updated

September 23, 2016

Record last verified: 2016-09

Locations

US(1)